Factory Mix-Up Ruins Up to 15 Million Vaccine Doses From Johnson & Johnson

WASHINGTON – Workers at a Baltimore plant that made two coronavirus vaccines accidentally merged the ingredients a few weeks ago, contaminating up to 15 million doses of Johnson & Johnson’s vaccine and forcing regulators to delay approving the plant’s production lines .

The facility is operated by Emergent BioSolutions, a manufacturing partner of Johnson & Johnson and AstraZeneca, the Anglo-Swedish company whose vaccine is not yet approved for use in the United States. Federal officials attributed the error to human error.

The mix-up has delayed future shipments of Johnson & Johnson cans in the U.S. while the Food and Drug Administration investigates what happened. Johnson & Johnson has strengthened its control over the work of Emergent BioSolutions to avoid additional quality defects.

The mistake is a major embarrassment for both Johnson & Johnson, whose single-dose vaccine is credited with accelerating the national vaccination program, and Emergent, its subcontractor, who has received heavy criticism for its strong lobbying for federal contracts, particularly for the emergency Government Health Stock.

The bug does not affect any Johnson & Johnson cans currently shipped and used nationwide, including shipments that states are anticipating next week. All of these cans were made in the Netherlands, where the operations were fully approved by federal regulators.

More shipments of the Johnson & Johnson vaccine – expected to be 24 million doses next month – should come from the huge Baltimore facility. These supplies are now in question while quality control issues are being resolved according to those familiar with the matter.

Federal officials are still expecting enough doses from Johnson & Johnson and the other two approved coronavirus vaccine manufacturers to meet President Biden’s commitment to provide enough vaccines to immunize every adult by the end of May.

Pfizer is shipping its doses ahead of schedule, and Moderna is about to approve the supply of vaccine bottles of up to 15 doses instead of 10, further strengthening the country’s inventory.

The problems arose at a new facility the federal government hired last year to manufacture vaccines from Johnson & Johnson and AstraZeneca. The two vaccines use the same technology, which uses a harmless version of a virus – known as a vector – that is transferred into cells to make a protein, which then stimulates the immune system to produce antibodies. However, the Johnson and Johnson and AstraZeneca vectors are biologically different and not interchangeable.

At the end of February, one or more employees somehow mixed up the two during the production process and raised questions about training and supervision. Over the past year, Emergent hired and trained hundreds of new employees to make millions of doses of both vaccines that should be ready by the time clinical trials showed that the vaccines were actually working.

Updated

March 31, 2021, 8:32 p.m. ET

Vaccine manufacturing is a notoriously capricious science, and errors are often expected to occur and ruin batches. However, Emergent’s mistake went undetected for days until Johnson & Johnson quality controls discovered it, according to people familiar with the situation. By then, up to 15 million cans were contaminated, people said.

None of the cans ever left the plant and the lot has been quarantined. There is no evidence that production of the AstraZeneca vaccine, which has not yet been approved by the Food and Drug Administration for emergency use, was affected.

Johnson & Johnson reported the mishap to federal regulators, who opened an investigation that delayed approval of the plant’s production lines. The company has increased the number of its own employees overseeing Emergent’s work and has introduced a number of new controls to protect against future errors.

Johnson & Johnson was already grappling with a manufacturing delay that caused the company to fail to meet its obligations to the federal government, but it appeared to be on track to catching up. 20 million doses had been administered by the end of March, and promises were made to dispense approximately another 75 million doses by the end of May.

White House officials backed up their predictions in a phone call with governors on Tuesday. They forecast certain shipments from Pfizer and Moderna, but warned that Johnson & Johnson shipments would fluctuate.

In a statement late Wednesday, the company said it expected the steps it is now taking with Emergent would allow it to drop 24 million doses by the end of April, or whatever the federal government expects. However, this depends on Johnson & Johnson’s compliance with the Food and Drug Administration regulations.

The agency last week cleared a bottling facility that Johnson & Johnson in Indiana is using to release more cans made in the Netherlands. However, this facility cannot ship cans made at the Emergent facility until the Food and Drug Administration approves it.

According to the Centers for Disease Control and Prevention, nearly seven million doses of the vaccine have been given to date, about half of which have been given.

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